Fensolvi® clinical study key endpoints summary 
- 0 patients withdrew from study due to Adverse Reactions
- Mean growth velocity decreased by 28% to near normal prepubertal rates from week 4 to week 48, from 8.9 cm/year to 6.4cm/year 
- Progression of clinical signs of puberty was arrested or reversed for majority of patients (57/59), as evidenced by regression or stabilization in Tanner staging 
- 87% of patients achieved primary efficacy endpoint of suppression of peak stimulated LH concentrations at Week 24 
- At least 85% of patients achieved LH levels of <4 IU/L at all time points throughout study 
- At least 97% of girls achieved estradiol suppression to prepubertal level throughout 48 weeks of treatment 
- FENSOLVI® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.
- Klein K, et al. Ped Endo Soc 2019. Accepted abstract.